(157 days)
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Not Found
No
The summary describes a standard immunoassay for T4 and contains no mention of AI or ML.
No.
The device is a test for the quantitative determination of T4 in blood specimens for screening newborns for congenital hypothyroidism, not a device used for treatment or therapy.
Yes
The device is intended for the quantitative determination of Thyroxine (T4) in blood specimens for screening newborns for congenital hypothyroidism, which is a diagnostic purpose.
No
The device description "AccuBind™ Neo-Natal T4 Microplate EIA" strongly suggests a hardware-based immunoassay kit, not a software-only device. The intended use also describes a laboratory test performed on blood specimens, which typically involves physical reagents and equipment.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism." This describes a test performed on a biological sample (blood) outside of the body (in vitro) to diagnose or screen for a medical condition (congenital hypothyroidism).
- Device Description: The device is described as a "Microplate EIA," which is a common format for in vitro diagnostic tests.
- Anatomical Site: The sample is "Blood specimens dried on the filter paper," which is a biological sample taken from the body.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.
Product codes
KLI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
newborns
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 2 2003
Dr. Jay Singh Consultant, Regulatory Affairs Monobind. Inc. 729 West 16th Street, Suite C-4 Costa Mesa, CA 92627
Re: K030860
Trade/Device Name: AccuBind™ Neo-Natal T4 Microplate EIA Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI Dated: June 27, 2003 Received: July 1, 2003
Dear Dr. Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K030860
Device Name: AccuBind™ Neo-Natal T4 Microplate ElA
The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
OR
Over-The-Counter (OTC) Use
(Per 21CFR 801.109)
(Optional Format 1-2-96).
Carol C Benson for Jean Cooper, Dr
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030860